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NCT Number: NCT05713968

Swallowing Evaluation by HRIM in Patients With Cervical Spondylosis

patients with cervical spondylolysis may have swallowing or eating difficulty. In this study, we will use high resolution impedance manometry to evaluate these patients' detailed swallowing mechanisms.

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Key information

Conditions

Upper Esophageal Sphincter Relaxing Pressure

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This study will aim to evaluate swallowing function in patients with cervical spondylolysis by using high resolution impedance manometry (HRIM) along with oral frailty and dysphagia questionnaires. Researchers will plan to enroll 50 patients to investigate this issue. The inclusion criteria will be as following:1) age higher or equal to 20 years old; 2) patients with cervical spondylolysis or associated symptoms. The exclusion criteria will be as following: major organ dysfunction, including chronic kidney disease, bleeding tendency. The primary outcome will be the upper esophageal sphincter relaxing pressure. The researchers will hope to find the swallowing dysfunction mechanisms in these patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with cervical spondylosis associated symptoms or expected to undergo cervical spine surgery
  • patients with associated swallowing difficulty symptoms

Exclusion criteria

  • major organ dysfunction, such as renal insufficiency or bleeding tendency

Treatment and study plan

patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM

Other

patients with EAT-10 higher than 3 or frailty questionnaire higher than 2 examined by HRIM

patients with EAT-10 lower than 3 or frailty questionnaire lower than 2

Other

patients with EAT-10 lower than 3 or frailty questionnaire lower than 2 examined by HRIM

Primary outcomes

  1. upper esophageal sphincter pressure

    Time frame: 30 minutes

    upper esophageal sphincter opening ability questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Chih-Jun Lai, MD

CONTACT

[email protected]

+886223123456

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Using High Resolution Impedance Manometry and Videofluoroscopic Measurements of Swallowing Function in Patients Undergoing Cervical Spine Patients

Important dates

Study start
2023
Primary completion
2027
Study completion
2029
First posted
Feb 6, 2023
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.